- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01053052
Study of FemVue(TM) Sono Tubal Evaluation System Method Comparison to HSG
A Comparative Study of Methods for Tubal Patency Determination and Uterine Cavity Evaluation: Sonography With the FemVue(TM) Catheter System vs. Hysterosalpingography (HSG)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Non-pregnant women between the ages of 18 and 45 who desire to know the patency status of the fallopian tubes and if the uterine cavity is free of pathology who have:
- Been attempting conception for 6 months or
A history of PID (including the conditions listed below) or
- Chlamydia
- Gonorrhea
- Endometriosis
- A history of pelvic surgery or
- Advanced maternal age (≥ 35) And
- Negative test for Gonorrhea/Chlamydia or prophylactic antibiotic treatment
- Without current bi-lateral tubal sterilization
- Signed Informed Consent
Exclusion Criteria:
Uterine anomaly or lesion(s) preventing catheter placement for either the FemVue or HSG procedure(as identified and documented by TVUS Screening procedure or the uterine cavity evaluation during the FemVue procedure or any previous diagnostic procedure)
- obstructing access to uterine cornu
- distorting fundus at the midline region
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sonography with FemVue vs. HSG
FemVue sonography and HSG
|
Sono HSG for FDA 510(k) cleared indication for use
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Concordance of evaluations of fallopian tube patency and intrauterine pathology.
Time Frame: Day 1
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
subject discomfort assessment
Time Frame: Day 1
|
Day 1
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Femasys 300-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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